BUNG PROCESSOR CUM STEAM STERILIZER VALIDATION PROTOCOL

September 30, 2018November 21, 2024 Pharmaceutical Guidanace

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The container closure components, garments, vial filling machine parts and miscellaneous items are required to be sterilized in an aseptic process. The Sterilization process using bung processor cum steam sterilizer is used for porous and nonporous loads. The autoclave sterilization process when challenged with Biological spores as Biological indicators (BI) is capable of achieving more than 12 log reduction in case of porous load and metallic load and 6 log reduction in case of liquid load. This process of sterilization of different loads in different loading patterns is required to be qualified as per GMP requirement.

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Thiruvananthapuram, Thuringia, Thurrock, Thurso, Tiaret, TIMOR-LESTE DILI, Tintagel, TIRANA, Tiruchirappalli, Tizi Ouzou, Tlemcen, TOGO, TOKYO, Tomsk, TONGA NUKUʻALOFA, Torbay, Trapani, Trento, Treviso, Trieste, TRINIDAD & TOBAGO, TRIPOLI, Truro, Tula, TUNIS, TUNISIA, Turin, turkey, TURKMENISTAN, TUVALU, Tver, Tyne and Wear, Tyumen, Udine, UGANDA, Ujjain, Ukraine, Ukraine. 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